In recent years there has been increased appreciation of the benefits provided by high fiber diets. These benefits include the reduction of gastrointestinal disorders and reduction of blood cholesterol levels. High fiber intake has even been correlated with decreased incidence of certain types of cancer. Low fat diets also provide health benefits. In addition to the obvious weight control benefits, it has been recognized in recent years that a low fat diet can significantly reduce blood cholesterol levels.
High blood cholesterol (hypercholesterolemia) is a significant risk factor in cardiovascular disease. Epidemiological studies have demonstrated that, with few exceptions, populations consuming large quantities of saturated fat and cholesterol have a relatively high concentration of serum cholesterol and a high mortality rate from coronary heart disease. While it is recognized that other factors can also contribute to the development of cardiovascular disease, there appears to be a causal relationship between high concentrations of serum cholesterol (hypercholesterolemia) which results in the accumulation of cholesterol in various parts of the circulatory system (arteriosclerosis) or in soft tissues (xanthomatosis), and coronary disease and coronary mortality rates.
The art describes the use of nonabsorbable, nondigestible, polyol polyesters as cholesterol lowering agents. U.S. Pat. No. 3,954,976, Mattson, et al., issued May 4, 1976, teaches pharmaceutical compositions for inhibiting absorption of cholesterol, comprising effective unit dosage amounts of a polyol fatty acid polyester having at least four C.sub.8 -C.sub.22 fatty acid ester groups. U.S. Pat. No. 4,005,195, Jandacek, issued Jan. 25, 1977, discloses anti-anal leakage agents used in combination with liquid polyol fatty acid polyesters to provide pharmaceutical and food compositions for treating and/or preventing hypercholesterolemia while avoiding undesired anal leakage of the liquid polyesters. U.S. Pat. No. 4,005,196, Jandacek et al., issued Jan. 25, 1977, discloses anti-anal leakage agents used in combination with vitamin-fortified liquid fatty acid polyester compositions for treating and/or preventing hypercholesterolemia while avoiding undesired anal leakage of the polyesters. U.S. Pat. No. 4,034,083, Mattson, issued July 5, 1977, comprises polyol fatty acid polyesters having at least four fatty acid ester groups which are fortified with fat-soluble vitamins and used in low-calorie foods and in pharmaceutical compositions for treating and/or preventing hypercholesterolemia in animals, especially humans.
Disclosures of polyol polyester compounds in food compositions include U.S. Pat. No. 3,579,548, Whyte, issued May 18, 1971, which teaches triglyceride esters of .alpha.-branched carboxylic acids, having the physical properties and utility of ordinary triglyceride fats but which are digested or absorbed to a lesser extent and are thus low calorie. These triglyceride esters are useful in making, for example, cakes. U.S. Pat. No. 3,600,186, Mattson, et al., issued Aug. 17, 1971, discloses low calorie food compositions produced by replacing at least a portion of the fat content of a conventional food with a sugar fatty acid polyester or sugar alcohol fatty acid polyester having at least 4 fatty acid ester groups with each fatty acid having from 8 to 22 carbon atoms. U.S. Pat. No. 4,368,213, Hollenbach, et al., issued Jan. 11, 1983, discloses a concentrated emulsion of non-absorbable liquid polyol polyesters and high melting fatty acids or esters thereof in water which can be diluted to a beverage. The emulsifier system comprises a polyglycerol ester and an aliphatic glycol ester. U.S. Pat. No. 4,461,782, Robbins, et al., issued July 24, 1984, discloses low calorie baked goods comprising from about 12% to about 60% of a non-absorbable, non-digestible, liquid polyol polyester, and from about 25% to about 85% microcrystalline cellulose or a mixture of microcrystalline cellulose and flour in a cellulose:flour weight ratio of at least 1:1.
Disclosures of the polyol polyester compounds in pharmaceutical compositions include U.S. Pat. No. 4,382,924, Berling, et al., issued May 10, 1983, which teaches edible compositions comprising edible oil or oil-like materials, a high potency, lipid-soluble sweetener, such as saccharin, and a lipid-soluble flavorant. These compositions are particularly useful as an oral dosage form for vitamins or pharmaceutical materials. The edible oil-like material may consist, in whole or in part, of an oily pharmaceutical agent, such as polyol fatty acid polyesters having at least four C.sub.8 -C.sub.22 fatty acid ester groups. U.S. Pat. No. 4,214,054, Volpenhein, et al., issued Dec. 23, 1980, teaches the use of polyol polyesters to detoxify humans and lower animals which have ingested toxic lipophilic compounds. U.S. Pat. No. 4,264,583, Jandacek, issued Apr. 28, 1981, discloses the oral administration of polyol fatty acid polyesters to dissolve radioluscent gallstones. In this treatment regimen, the polyesters may be administered alone or, preferably, in conjunction with a litholytic bile acid.
U.S. Pat. Nos. 3,963,699, Rizzi, et al., issued June 15, 1976; 4,517,360, Volpenhein, issued May 14, 1985; and 4,518,772, Volpenhein, issued May 14, 1985, all disclose methods of synthesis for higher polyol fatty acid polyesters.
J. E. Garbin, D. T. Forman, W. R. Eiseman, and C. R. Phillips, Proc. Soc. Exp. Biol. Med., 120, 744 (1965), describe the administration of psyllium (as METAMUCIL brand laxative) to human volunteers, resulting in a reduction in blood cholesterol levels. Also, see Forman, et. al., Proc. Soc. Exp. Biol. Med., 127, 1060-1063 (1968).
Generally, psyllium, whether used for controlling constipation or diarrhea, or for reducing blood cholesterol levels, is introduced into the diet by dispersing it in water or an aqueous beverage which is ingested by the user.
Psyllium mucilloid contains natural mucillage and normally forms a gelatinous mass on contact with water. It also exhibits poor dispersibility and mixability in water. The numerous individual particles tend to agglomerate when psyllium mucilloid is mixed in water. Hydration takes place over the surface of such agglomerated aggregates to form gel-coated lumps, the interiors of which are still substantially dry, and these lumps are extremely difficult to disperse. This effect is aggravated by the fact that psyllium has a tendency to float on the surface of the water, allowing partially dissolved particles to agglomerate into large masses. Such imperfect dispersions are generally not considered to be palatable. In addition, even when properly dispersed, the taste and texture of psyllium mucilloid are undesirable to many persons.
A number of methods have been suggested or obviating these problems. Historically, psyllium seed preparations have been formulated to contain equal parts of active bulk laxative and a sugar as a means of promoting dispersion. These products are undesirable to many persons because of their high sugar and calorie content.
U.S. Pat. No. 3,455,714, Bishop et al., issued July 15, 1969, discloses a method for providing water-soluble gums having improved water dispersibility comprising coating the gums with certain water-soluble cellulose ethers, water-soluble cellulose esters, and water-soluble mixed cellulose esters which do not agglomerate when added to water or have less of a tendency to agglomerate than the materials being coated therewith. U.S. Pat. No. 4,321,263, Powell et al., issued Mar. 23, 1982, discloses a method for rendering psyllium powder more easily dispersed in water by wetting the psyllium particles with an alcoholic solution of at least one polyethylene glycol and polyvinylpyrrolidone and granulating the thus-coated particles.
U.S. Pat. No. 4,565,702, Morley, et al., issued Jan. 21, 1986, teaches a dietary fiber composition prepared by coating an insoluble fiber with a soluble fiber. The insoluble fiber may be psyllium. The dietary fiber composition can be used to prepare low calorie, high fiber content dietary food products.
Finally, European Patent Application 144,644, published June 19, 1985, discloses a composition comprising from about 25% to about 100% (by weight) total dietary fiber selected from psyllium, and a grain, fruit, or vegetable source, wherein psyllium comprises from about 10% to about 80% of the fiber. The dry blend or high fiber food product base is incorporated into suitable compositions to provide a psyllium high fiber drink mix or an extruded psyllium high fiber bar or puff which may additionally contain sweeteners, flavoring agents, protein sources, surfactants, wetting agents, preservatives, and the like.
Cookies or biscuits might provide a useful way to introduce psyllium into the diet. However, attempts to incorporate psyllium into baked goods have historically met with difficulty due to the mucillaginous nature of psyllium. If the psyllium is hydrated before the compositions are baked, an undesirable product results. Not only is the product difficult to work with, but the resulting baked product has an undesirable taste and texture.
It would be most desirable to make a palatable psyllium-containing cookie in which the psyllium does not substantially hydrate during the mixing, forming, or baking process, and does not substantially hydrate in the mouth upon eating.
An object of the present invention is to provide a method for making such a psyllium-containing cookie.
A further object of the present invention is to provide a composition and method for making a palatable psyllium- and polyol polyester-containing cookie.
A further object of the present invention is to provide a method for reducing blood cholesterol in a patient in need of such treatment, comprising the administration to the patient of said psyllium-containing or said psyllium- and polyol polyester-containing cookie.
Yet a further object of the present invention is to provide a method for treating gastrointestinal disorders (such as constipation or diarrhea) in a patient in need of such treatment, comprising the administration to the patient of said psyllium-containing cookie.